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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Coagulation Factor IX (recombinant)
Trade Name: BeneFix
Date Designated: 10/03/1994
Orphan Designation: Treatment of hemophilia B
Orphan Designation Status: Designated/Approved
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
235 E. 42nd St 219/9/1
New York, New York 10017
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Coagulation Factor IX (recombinant)
Trade Name: BeneFix
Marketing Approval Date: 02/11/1997
Approved Labeled Indication: For the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency and Christmas disease), including control and prevention of bleeding in surgical settings.
Exclusivity End Date: 02/11/2004 
Exclusivity Protected Indication* :  
2 Generic Name: Coagulation Factor IX (recombinant)
Trade Name: BeneFix
Marketing Approval Date: 06/26/2020
Approved Labeled Indication: Routine prophylaxis to reduce the frequency of bleeding episodes in patients 16 years of age and older with hemophilia B (congenital factor IX deficiency or Christmas disease).
Exclusivity End Date: N/A  
3 Generic Name: Coagulation Factor IX (recombinant)
Trade Name: BeneFix
Marketing Approval Date: 10/05/2021
Approved Labeled Indication: Routine prophylaxis to reduce the frequency of bleeding episodes in adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease)
Exclusivity End Date: N/A  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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